FDA 483 - Nico de Vries, M.D. - August 09, 2013

An FDA inspection of Nico de Vries, M.D., Principal Investigator, in Amsterdam, revealed significant deficiencies in the conduct of a clinical study. Key issues included inaccurate and incomplete adverse event records, as well as improper and outdated informed consent documentation. These findings indicate a failure to adequately protect subject rights and welfare, and to adhere to the investigational plan.